OMNISPAN ORTHOCORD · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

17 linked reportsMalfunction 12Injury 5

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	4	4.57
2019-02	0	2.6
2019-03	1	3.45
2019-04	2	3.33
2019-05	0	3.15
2019-06	0	3.11
2019-07	1	3.62
2019-08	0	3.74
2019-09	0	3.92
2019-10	4	3.72
2019-11	0	4.59
2019-12	0	4.75
2020-01	0	4.79
2020-02	0	3.72
2020-03	0	4.43
2020-04	0	5.91
2020-05	0	4.24
2020-06	0	4.29
2020-07	2	4.32
2020-08	0	4.54
2020-09	0	3.97
2020-10	0	4.51
2020-11	0	5.97
2020-12	0	5.53
2021-01	0	5.32
2021-02	0	4.7
2021-03	0	4.81
2021-04	0	5.04
2021-05	0	4.72
2021-06	0	4.26
2021-07	0	4.85
2021-08	0	4.52
2021-09	0	4.68
2021-10	0	4.98
2021-11	0	5.09
2021-12	0	5.04
2022-01	0	4.67
2022-02	0	4.37
2022-03	1	4.86
2022-04	0	4.45
2022-05	0	4.93
2022-06	0	4.22
2022-07	1	4.36
2022-08	0	5.82
2022-09	0	4.68
2022-10	0	5.29
2022-11	0	4.83
2022-12	0	5.4
2023-01	1	5.58
2023-02	0	5.46
2023-03	0	6.1
2023-04	0	6.58
2023-05	0	6.67
2023-06	0	7.12
2023-07	0	6.4
2023-08	0	6.63
2023-09	0	5.65
2023-10	0	6.61
2023-11	0	4.84
2023-12	0	6.41
2024-01	0	5.68
2024-02	0	6.45
2024-03	0	8.97
2024-04	0	13.7
2024-05	0	13.88
2024-06	0	14.96
2024-07	0	13.82
2024-08	0	8.5
2024-09	0	8.31
2024-10	0	6.11
2024-11	0	6.2
2024-12	0	5.48
2025-01	0	5.69
2025-02	0	4.69
2025-03	0	5.06
2025-04	0	5.32
2025-05	0	5.79
2025-06	0	5.63
2025-07	0	5
2025-08	0	5.41
2025-09	0	4.37
2025-10	0	4.79
2025-11	0	6.43
2025-12	0	5.95
2026-01	0	5.86
2026-02	0	6.39
2026-03	0	5.9
2026-04	0	6.05
2026-05	0	6.75
2026-06	0	6.75

This device (reports/month)Average device in GAT, HTY, JDR, MAI, MBI, NEW (reports/device/month)

Failure-mode summaryAI-generated

17 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2023-01-24	1221934-2023-00452	Malfunction	Available	exact di
2022-07-12	1221934-2022-02121	Injury	Available	exact di
2022-03-01	1221934-2022-00659	Malfunction	Available	exact di
2020-07-02	1221934-2020-01745	Injury	Available	exact di
2020-07-02	1221934-2020-01741	Injury	Available	exact di
2019-10-25	1221934-2019-59228	Malfunction	Available	exact di
2019-10-25	1221934-2019-59223	Malfunction	Available	exact di
2019-10-25	1221934-2019-59221	Malfunction	Available	exact di
2019-10-25	1221934-2019-59227	Malfunction	Available	exact di
2019-07-03	1221934-2019-57544	Malfunction	Available	exact di
2019-04-02	1221934-2019-56734	Injury	Available	exact di
2019-04-02	1221934-2019-56736	Injury	Available	exact di
2019-03-29	1221934-2019-56718	Malfunction	Available	exact di
2019-01-29	1221934-2018-53741	Malfunction	Available	exact di
2019-01-29	1221934-2019-56199	Malfunction	Available	exact di

Showing 1–15 of 17

Regulatory clearances

510(k)K092836Substantially equivalent (SESE) · 2010-02-04clearance family

Predicate lineage

K092836

Cited as predicate by: K153667

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

None in the loaded window.

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